The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline. The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings. Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
603
PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
Znfpc Spilhaus Center
Harare, Zimbabwe
To assess the safety of the PrePex device when circumcision is performed by nurses
To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate when circumcision is performed by nurses
Time frame: 9 weeks
Evaluate the training needs of PrePexTM deployment using nurses
1. PrePex Procedure time and the resulting cost of provider's time 2. Cost Effectiveness • Cost of device 3. Evaluation of the PrePex training needs and efficacy 4. Acceptability of the PrePex procedure by the patients
Time frame: 9 weeks
Observation of in-field usability of device
Observation of in-field usability of device using questionnaires
Time frame: 9 weeks
Obtain user feedback from nurses
Obtain user feedback from nurses by questionnaires
Time frame: 9 weeks
Assess safety compared to physician deployment
1\. To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate, when circumcision is performed by nurses comparing to Physicians.
Time frame: 9 weeks
Assess practicality and acceptability among nurses and patients
Assess practicality and acceptability among nurses and patients using questionnaires.
Time frame: 9 weeks
Assess satisfaction of procedure among nurses and patients
Assess satisfaction of procedure among nurses and patients using questionnaires.
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Time frame: 9 weeks
Determine cost-effectiveness compared to surgical procedure
1\. Evaluating the cost-effectiveness when taking into account the following parameters: i. PrePex Procedure time and the resulting cost of provider's time compared to surgical procedure ii. Cost of device compared to surgical procedure iii. Cost of device training compared to surgical procedure training iv. Cost of staff time for follow-up visits compared to compared to surgical procedure staff time v. Cost of equipment and supplies needed for the circumcision procedure for both PrePex and surgical circumcision.
Time frame: 9 weeks